Collecting information
Organizing data
The Quality/PI Supervisor is also responsible for developing, implementing, coordinating, and monitoring performance improvement strategies to improve patient safety, establish evidence-based care, and meet organizational goals. Collaborates with leaders, physicians, nurses, allied health professionals, and support staff to develop performance improvement initiatives that address quality of care opportunities. Utilizes evidence-based clinical guidelines and best practice to guide process improvement related to targeted clinical diagnoses, regulatory requirements, and patient safety. Supports patient safety program in collaboration with the Quality and Patient Safety Department, Regulatory Affairs, and Risk Management and Medical Staff Services. Knowledge of Joint Commission and Centers for Medicare and Medicaid Services regulations/requirements preferred.
The Manager of Specialty Pharmacy Operations is responsible for overseeing the strategic, financial, and operational aspects of client specialty pharmacy services. Oversee daily specialty pharmacy care coordinators, ensuring efficiency, accuracy, and compliance. Education: Bachelor’s or Doctor of Pharmacy (PharmD) required; Master’s in Business Administration (MBA) or Healthcare Administration (MHA) preferred. Experience: Minimum 7–10 years of experience in pharmacy operations, including at least 5 years in a leadership role in specialty pharmacy. Strong understanding of specialty pharmacy regulations, payer models, and accreditation standards.
Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity.. Maintain an audit and inspection program to support GCP regulatory inspections.. Use the quality assurance process as an opportunity for continuing education of study teams.. Minimum 3 years of relevant audit experience in a FDA Environment such as pharmaceutical, biotech or CRO company or similar environment required.. Knowledge of Electronic Data Capture Systems such as Medidata RAVE.
As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance, you will lead the development of labeling for clinical supplies as well as development of commercial labeling materials for Olema products. This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research/development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply, and CMC teams. 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical.
The Director will be the Category Leader for the category assigned to them within the Strategic Sourcing and Procurement (SS&P) department. This individual will be the key point of contact for their category and will be responsible for providing strategic leadership, operational oversight, and administrative/HR management for direct reports and extended leadership for indirect reports. The Director, Sourcing will be a Category Leader for the Development Category encompassing Clinical Labs, Clinical Pharmacology, Translational Research, Global Patient Safety, Regulatory Affairs, Medical Affairs, Clinical Development, and Biometrics. This role will support outsourcing needs to advance Exelixis R&D efforts, including services such as consulting, medical science liaison, pharmacovigilance, quality assurance, central labs, local lab results integration, PK and immunogenicity bioanalysis, biomarker assays, ADME studies, and toxicology. Deep knowledge of outsourcing concepts, financial processes, contracts, regulations (FDA, EMA, ICH GCP), and industry standards.
The Patient Care Coordinator is responsible for overseeing the management and coordination of care for the acute inpatient population.. The PCC collaborates with rounding MAPMG Hospital Based Service Physicians, patient/family, nursing, utilization review and other members of the healthcare team to assure continuum of patient care progression for clinical and cost-effective outcomes.. Send referrals/communicate with in-network vendors for coordination of post-acute levels of care such as Home Health, DME, IV infusion, SNF, Sub-Acute and Acute Rehab.. Some awareness or knowledge of health/care reimbursement systems (Medicare Advantage, Commercial payer, Medicaid and CMS regulatory rules).. Annually: Successful completion of PCC Assessment of Critical Skills, Passing score on inter-rater reliability.
SummaryThis position in the Department of Ophthalmology leads the clinical research unit by overseeing staff and management of clinical research studies, ensuring compliance with study protocols, institutional policies, and GCP guidelines.. The ideal candidate will have prior experience in ophthalmology or demonstrate the ability to quickly learn and support a wide range of ophthalmic assessments such as OCT, visual field testing, and fundus imaging.. Supervises the day-to-day operations of clinical trials, including patient recruitment, informed consent, data collection, and regulatory documentationEnsures compliance with IRB, FDA, and sponsor requirements, and maintains accurate and timely study records.. Coordinates with sponsors, CROs, and institutional departments to facilitate study start-up, monitoring, and closeout activities.. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Position Summary The Principal, Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.. Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.. Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.. Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks. Exempt Employees are eligible for Unlimited PTO
The Regulatory and Clinical Specialist will support the clinical evaluation activities, review promotional materials and support regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The Regulatory and Clinical Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.. Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.). Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature. experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, technical files).. EducationMinimum of a master's degree in biomedical engineering, science or equivalent technical discipline and at least 5 years of previous related experience in medical writing and medical device regulatory affairs or a Ph. D. with at least 3 years of experienceTravel RequirementsOccasional travel may be required ~10Pay TransparencyA reasonable estimate of the annual base salary for this position is $70,000 - $95,000 plus discretionary annual bonus.
LOCATION: East Providence, Rhode IslandDAYS: Monday - FridayHOURS: 40/week Full Time Benefits EligiblePosition Summary:Under the supervision of the Laboratory Director, the Quality Assurance (QA) Manager coordinates the activities of the Laboratory's QA department.. Together with Laboratory Director, develop, implement and evaluate a quality management plan which ensures the delivery of high quality services to patients and clients.. Acts as ESCL's liaison with HIPAA Compliance Officer.. Rhode Island Clinical Laboratory Scientist license or equivalent documentation from another state required (ASCP).. Excellent working knowledge of accreditation inspections, HIPAA, State Privacy Laws, Stark, and Proficiency Testing.
This role operates independently but collaborates closely with the research coordinator team, Clinical Trials Manager, Investigators, and study sponsors to maintain compliance with all clinical trial conduct requirements.. Serve as an in-house phlebotomist for all active clinical trials, including responsibilities for drawing blood, processing blood and urine samples, packaging, and shipping out all samples in adherence to applicable protocols.. Support the start-up and close-out of clinical trials through training, source creation, and process development.. Qualified candidates with criminal history and/or driving violations will be considered and are not automatically disqualified, consistent with applicable federal law, state law (the California Fair Chance Act), and local ordinances (San Francisco Fair Chance Ordinance, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County's Fair Chance Ordinance for Employers).. Qualified candidates with criminal history will be considered and are not automatically disqualified, consistent with applicable federal law, state law (the California Fair Chance Act), and local ordinances (San Francisco Fair Chance Ordinance, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County's Fair Chance Ordinance for Employers).
You will be the Regulatory Advisor and function as the “R” in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP).. You will be product or project business lead for global CMRP at Takeda. CMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment.. Exercise decision-making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values.. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.
Principal Investigator (PI) – Clinical Research Global Clinix is seeking a dedicated and experienced Principal Investigator (PI) with a background in Internal Medicine, Family Medicine, or any specialty to join our dynamic clinical research team.. The PI will play a pivotal role in ensuring protocol compliance, patient safety, and regulatory adherence while supporting the success and integrity of ongoing and future clinical trials.. Report serious adverse events (SAEs) and safety concerns in a timely and accurate manner to the sponsor and IRB. Preferred experience in clinical trials, either as a Principal Investigator or Sub-Investigator. Strong understanding of Good Clinical Practice (GCP) and applicable FDA regulations
I. JOB OVERVIEW Job Description Summary: The Senior Financial Analyst, Clinical Research is the primary contact in the GWCC Clinical Trials Office responsible for monitoring funds flow and ensuring the accuracy. This position works collaboratively with SMHS finance and the GWU Office of Clinical Research (GWOCR) in compliance, technical, fiscal, and administrative services required to support cancer clinical trials including, clinical research billing compliance, invoicing, and financial reporting. Assist with monthly billing/invoicing for funded clinical trials verifying financial data for accuracy, completeness and conformance with clinical trial study budgets, includes accurate input of budget and payment milestones into tracking system, must be able to follow monthly tracking of payments and payment issues so that contracts and budgets can be renegotiated if necessary Assist in monitoring outstanding invoices, tracking collection, reducing accounts receivable balance. Follow institutional guidelines and policies in performing Medicare Coverage Analysis (MCA). May assist with negotiations of individual budgets with sponsors, able to challenge claims made by sponsors on what they feel is appropriate, able to cover costs for GW Cancer Center, asking for appropriate funding and being able to say “no” to a sponsor without anxiety or anger, keeping GW competitive with other institutions.
PathAI is seeking a Senior Clinical Scientist to play a key role in driving our in vitro diagnostic (IVD) device projects, strategy and roadmaps.. Study Design & Documentation Develop and author clinical protocols, study reports, and regulatory submission documents in compliance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) guidelines.. Support data review and interpretation to ensure clinical relevance and regulatory compliance.. Advanced degree (PhD, MD, PharmD, or equivalent) in a relevant scientific discipline such as biomedical sciences, pathology, or clinical research.. 3+ years of experience in clinical development, clinical trials, or regulatory affairs within diagnostics, medical devices, or biotech/pharmaceutical industries.
Will serve as the Health Policy SME for the program and stakeholders for value-based payment models, Fraud, waste and abuse analytics, quality measures reporting and other clinical or patient safety initiatives.. Oversees and manages staffing, recruitment/talent acquisition, finances, ROI, profitability, and operations for the program.. Must have adept knowledge of CMS (Centers for Medicare and Medicaid) Value Based Payment Models, as well as experience supporting various aspects of CMMI (CMS Innovation Center).. A background in Health Informatics is ideal for success in this position.. Must have a bachelor's degree in business, project management, healthcare informatics, or related field.
Under limited supervision, and with the latitude for initiative and independent judgment, performs, coordinates, and manages the creation and outsourcing of billing analysis in accordance with the Center for Medicaid and Medicare Services (CMS) regulations and the Clinical Trial Policy for all clinical trials.. The billing analysis must be compliant with the Medicare billing rules.. Performs basic and complex billing and budget analysis in accordance with CMS regulations for all clinical trials performed at UMMS affiliates and FPI practice offices and clinics.. Applies the appropriate CDM and/or CPT codes for potentially billable items in the coverage analysis in order to assist in the management of claims review, as well as identifying items that are to be billed to the sponsor via the budgeting and contract teams at the Office of Research and Development (ORD) at University of Baltimore (UMB).. Bachelor’s degree in Healthcare Administration, Medical Coding, Auditing, Finance, Accounting, Nursing, or a related field required.
Under limited supervision, and with the latitude for initiative and independent judgment, performs, coordinates, and manages the creation and outsourcing of billing analysis in accordance with the Center for Medicaid and Medicare Services (CMS) regulations and the Clinical Trial Policy for all clinical trials. The billing analysis must be compliant with the Medicare billing rules. Performs basic and complex billing and budget analysis in accordance with CMS regulations for all clinical trials performed at UMMS affiliates and FPI practice offices and clinics. Applies the appropriate CDM and/or CPT codes for potentially billable items in the coverage analysis in order to assist in the management of claims review, as well as identifying items that are to be billed to the sponsor via the budgeting and contract teams at the Office of Research and Development (ORD) at University of Baltimore (UMB). Bachelor’s degree in Healthcare Administration, Medical Coding, Auditing, Finance, Accounting, Nursing, or a related field required.
Works with the Manager of Clinical Research Finance & Systems in developing budgets that are fiscally sound and inclusive of all potential expenses.. Works with Research Regulatory Affairs to ensure timely IRB submission and regulatory compliance.. Creates, updates, and manages research unit policies and procedures demonstrating an in-depth understanding of FDA and IRB Regulations and ICH/GCP Guidelines.. Education: Bachelor’s Degree in Biology, Chemistry, Behavioral Science, Science, Health, or Nursing required.. Special Training, Certification or Licensure: Current Clinical Research Coordinator or Clinical Research Associate Certification preferred.
Supports study-responsible physician (SRP) and/or lead junior clinical research scientist in execution of clinical trials.. Reviews and adjudicates study subject eligibility and protocol deviations and responds to specific site protocol questions, working closely with the SRP and/or lead clinical research scientist.. Actively participates in or leads the development of Clinical Study Protocols and Protocol Amendments, Informed Consent Forms, Investigator Brochures, Development Safety Update Reports, Clinical Study Reports, Safety Review Committee charters, study plans (e.g., Medical Data Review, Medical Monitoring, Cohort Management, Protocol Deviation Plans) and publications in collaboration with the SRP and/or lead clinical scientist.. Collaborates with lead clinical scientists, SRP, biometrics, pharmacovigilance and data management to plan and execute the analysis of clinical data.. Identifies emerging data trends, communicates and discusses trends with SRP and pharmacovigilance scientist, when appropriate.